Threshold commences combination Phase 1/2 trial of TH-302 and sunitinib for RCC, GIST and PNET

Threshold Pharmaceuticals, Inc. (Nasdaq: THLD), today announced the initiation of a Phase 1/2 dose escalation clinical trial of TH-302 in combination with sunitinib in patients with advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) and pancreatic neuroendocrine tumor (PNET). TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia. Sunitinib, marketed by Pfizer under the brand name Sutent^®, is an oral, small molecule angiogenesis inhibitor that is currently approved for the treatment of RCC, GIST and PNET.

“I am hopeful that TH-302 may prove to be an effective new agent for the treatment of renal cell carcinoma.”

"The treatment of solid tumors continues to be a difficult therapeutic challenge. While the introduction of anti-angiogenics has enabled significant efficacy improvements, most patients ultimately relapse. There is now increasing evidence that anti-angiogenics induce tumor hypoxia. Therefore, adding TH-302 to an agent like sunitinib holds the promise of broader treatment coverage of the tumor than would be achieved by either agent alone. Indeed, this underlying scientific rationale combined with Threshold's preclinical work in RCC models drove the initiation of this study," said Dr. Alexander Starodub, M.D., Indiana University Health Goshen Center for Cancer Care and principal investigator for the trial. "I am hopeful that TH-302 may prove to be an effective new agent for the treatment of renal cell carcinoma."